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Lidocaine Infusion for Postthoracotomy Pain Syndrome (LIPPS)

Primary Purpose

Thoracic Surgery, Video-Assisted, Lidocaine, Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lidocaine
Control
Sponsored by
Guangzhou First People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Surgery, Video-Assisted focused on measuring postthoracotomy pain syndrome, chronic pain, lidocaine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled to undergo a muscle-sparing lateral minithoracotomy for different thoracic diseases

Exclusion Criteria:

  • (1)ASA classification status III or above
  • (2)Body weight<35kg
  • (3)Liver cirrhosis
  • (4)A history of previous thoracotomy
  • (5)Pregnancy
  • (6)Severe arrhythmia
  • (7)Congestive heart failure
  • (8)Opioid or steroid use 6 months before surgery
  • (9)Allergy to lidocaine
  • (10)Chronic pain syndrome (any type)
  • (11)Emergency surgery
  • (12)Incapacity to give an informed consent, Visual dysfunction or severe mental disorders

Sites / Locations

  • Guangzhou First People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine

Control

Arm Description

Lidocaine treatment

Placebo treatment

Outcomes

Primary Outcome Measures

Occurrence of chronic pain
Chronic pain was assessed in accordance with the IMMPACT recommends in the domains of: (1) absence or presence of pain in the area of the surgery, (2) clinically important (NRS ≥ 4 on a 0- to 10-point scale) daily average pain, (3) clinically important pain at rest, (4) clinically important pain intensity upon movement or activity, (5) pain qualities, and (6) physical and emotional functioning.

Secondary Outcome Measures

Postoperative acute pain
Use numeric rating scale (NRS) to assess the postoperative acute pain
Sedation
Use numeric rating scale (NRS) to asses
Postoperative nausea and vomiting (PONV) nausea
Use numeric rating scale (NRS) to assess
Fatigue
Use numeric rating scale (NRS) to assess
Occurrence of chronic pain at 6-month
Chronic pain was assessed in accordance with the IMMPACT recommends in the domains of: (1) absence or presence of pain in the area of the surgery, (2) clinically important (NRS ≥ 4 on a 0- to 10-point scale) daily average pain, (3) clinically important pain at rest, (4) clinically important pain intensity upon movement or activity, (5) pain qualities, and (6) physical and emotional functioning.

Full Information

First Posted
September 9, 2018
Last Updated
November 5, 2018
Sponsor
Guangzhou First People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03666299
Brief Title
Lidocaine Infusion for Postthoracotomy Pain Syndrome
Acronym
LIPPS
Official Title
Lidocaine Infusion for Postthoracotomy Pain Syndrome, A Prospective, Randomized, Double-blind, Placebo-controlled Trial (LIPPS Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 6, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou First People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study seeks to investigate lidocaine infusion to reduce postthoractomy pain syndrome after thoracic Surgery
Detailed Description
Postthoracotomy pain syndrome (PPS) is defined as a persistent and/or recurrent pain or burning sensation along the thoracotomy scar at 3 months after surgery. The pain is very significant, given that 3 to 5% of postthoractomy patients report it as being severe, and approximately 50% of patients report limitations in their activities of daily living. Little is known about the origin of this pain, but it seems that the intensity of acute postoperative pain is the best predictor of it. Lidocaine infusion could be a possible approach to reducing the prevalence of PPS. Recently, a meta-analysis concluded a modest but statistically significant reduction of pain severity in the first four postoperative hours measured by the visual analogue scale (mean difference, -0.84; 95% CI, -1.10 to -0.59). However, a more recent meta-analysis found that only limited clinical data and biological plausibility support lidocaine infusions for the prevention of postoperative persistent pain (odds ratio, 0.29; 95% CI, 0.18 to 0.48). This study was designed to investigate whether lidocaine infusion after video-assisted thoracoscopic surgery (VATS) would lower PPS at postoperative 3 and 6 month.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Surgery, Video-Assisted, Lidocaine, Pain, Postoperative, Chronic Pain
Keywords
postthoracotomy pain syndrome, chronic pain, lidocaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Experimental
Arm Description
Lidocaine treatment
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo treatment
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
intravenous lidocaine infusion
Intervention Description
Infusion of 2% lidocaine hydrochloride at 4 mL/h, started after tracheal intubation and discontinued until 24 h after surgery.
Intervention Type
Drug
Intervention Name(s)
Control
Other Intervention Name(s)
normal saline control
Intervention Description
Infusion of normal saline at 4 mL/h, started after tracheal intubation and discontinued until 24 h after surgery.
Primary Outcome Measure Information:
Title
Occurrence of chronic pain
Description
Chronic pain was assessed in accordance with the IMMPACT recommends in the domains of: (1) absence or presence of pain in the area of the surgery, (2) clinically important (NRS ≥ 4 on a 0- to 10-point scale) daily average pain, (3) clinically important pain at rest, (4) clinically important pain intensity upon movement or activity, (5) pain qualities, and (6) physical and emotional functioning.
Time Frame
At 3 months after surgery.
Secondary Outcome Measure Information:
Title
Postoperative acute pain
Description
Use numeric rating scale (NRS) to assess the postoperative acute pain
Time Frame
postoperative days 1 and 2.
Title
Sedation
Description
Use numeric rating scale (NRS) to asses
Time Frame
postoperative days 1 and 2.
Title
Postoperative nausea and vomiting (PONV) nausea
Description
Use numeric rating scale (NRS) to assess
Time Frame
postoperative days 1 and 2.
Title
Fatigue
Description
Use numeric rating scale (NRS) to assess
Time Frame
postoperative days 1 and 2.
Title
Occurrence of chronic pain at 6-month
Description
Chronic pain was assessed in accordance with the IMMPACT recommends in the domains of: (1) absence or presence of pain in the area of the surgery, (2) clinically important (NRS ≥ 4 on a 0- to 10-point scale) daily average pain, (3) clinically important pain at rest, (4) clinically important pain intensity upon movement or activity, (5) pain qualities, and (6) physical and emotional functioning.
Time Frame
At 6 months after surgery.
Other Pre-specified Outcome Measures:
Title
Postthoracotomy ipsilateral shoulder pain
Description
Use numeric rating scale (NRS) to assess
Time Frame
postoperative days 1 and 2.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled to undergo a muscle-sparing lateral minithoracotomy for different thoracic diseases Exclusion Criteria: (1)ASA classification status III or above (2)Body weight<35kg (3)Liver cirrhosis (4)A history of previous thoracotomy (5)Pregnancy (6)Severe arrhythmia (7)Congestive heart failure (8)Opioid or steroid use 6 months before surgery (9)Allergy to lidocaine (10)Chronic pain syndrome (any type) (11)Emergency surgery (12)Incapacity to give an informed consent, Visual dysfunction or severe mental disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangcai Ruan, PhD
Phone
+8620-81048306
Email
xc_ruan@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Danyang Pan, MD
Phone
+86-13246886285
Email
Pandy0505@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangcai Ruan, PhD
Organizational Affiliation
Affliated First People's Hospital of Guangzhou ,Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Luo, MD
Phone
020-81045412
Email
MEC_GZSY@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28115872
Citation
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Results Reference
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PubMed Identifier
25670347
Citation
Slovack M, Taylor B, Bryce R, Ong D. Does intravenous lidocaine infusion during video-assisted thoracoscopic surgery reduce postoperative analgesia? A randomized controlled study. Can J Anaesth. 2015 Jun;62(6):676-7. doi: 10.1007/s12630-015-0333-z. Epub 2015 Feb 11. No abstract available.
Results Reference
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PubMed Identifier
25899956
Citation
Brulotte V, Ruel MM, Lafontaine E, Chouinard P, Girard F. Impact of pregabalin on the occurrence of postthoracotomy pain syndrome: a randomized trial. Reg Anesth Pain Med. 2015 May-Jun;40(3):262-9. doi: 10.1097/AAP.0000000000000241.
Results Reference
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PubMed Identifier
26184397
Citation
Kranke P, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Weibel S. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery. Cochrane Database Syst Rev. 2015 Jul 16;(7):CD009642. doi: 10.1002/14651858.CD009642.pub2.
Results Reference
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PubMed Identifier
29757886
Citation
Bailey M, Corcoran T, Schug S, Toner A. Perioperative lidocaine infusions for the prevention of chronic postsurgical pain: a systematic review and meta-analysis of efficacy and safety. Pain. 2018 Sep;159(9):1696-1704. doi: 10.1097/j.pain.0000000000001273.
Results Reference
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PubMed Identifier
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Citation
Bunchungmongkol N, Pipanmekaporn T, Paiboonworachat S, Saeteng S, Tantraworasin A. Incidence and risk factors associated with ipsilateral shoulder pain after thoracic surgery. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):979-82. doi: 10.1053/j.jvca.2013.10.008. Epub 2014 Jan 18.
Results Reference
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PubMed Identifier
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Citation
Martinez-Barenys C, Busquets J, de Castro PE, Garcia-Guasch R, Perez J, Fernandez E, Mesa MA, Astudillo J. Randomized double-blind comparison of phrenic nerve infiltration and suprascapular nerve block for ipsilateral shoulder pain after thoracic surgery. Eur J Cardiothorac Surg. 2011 Jul;40(1):106-12. doi: 10.1016/j.ejcts.2010.10.025. Epub 2010 Dec 8.
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Citation
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Citation
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Results Reference
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Lidocaine Infusion for Postthoracotomy Pain Syndrome

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